UMIN-CTR Clinical Trial

Public title

A randomized controlled trial for the effectiveness of self-management education using structured self-monitoring of blood glucose in noninsulin-treated type 2 diabetes patients

Acronym

Effectiveness of structured self-monitoring of blood glucose in noninsulin-treated type 2 diabetes patients(RCT)

Scientific Title

A randomized controlled trial for the effectiveness of self-management education using structured self-monitoring of blood glucose in noninsulin-treated type 2 diabetes patients

Scientific Title:Acronym

Effectiveness of structured self-monitoring of blood glucose in noninsulin-treated type 2 diabetes patients(RCT)

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness of self-management education using structured self-monitoring of blood glucose in noninsulin-treated type 2 diabetes patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in HbA1c (after 6 months and 12 months from starting SMBG use)

Key secondary outcomes

1.Self-efficacy for health behavior
2.health and life habit
3.health literacy
(after 6 months and 12 months from starting SMBG use)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

1.7-point SMBG(fasting, preprandial/2-h postprandial at meal time, bed time) on 3 consecutive days every two months and recording
2.Comments to results of SMBG from physicians and nurses in outpatient clinic

Interventions/Control_2

Usual diabetes self-management education

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

25

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.type 2 diabetes> 1 years
2.HbA1c level 7-12%(NGSP)
3.Noninsulin treatment and nonincretin injection treatment
4.not routine use of SMBG
5.currently treated by diet, exercise, oral diabetes medication
6.able to complete self-reported questionnaires

Key exclusion criteria

1. type 1 diabetes
2. currently treated by dementia, psychosis, recent emotional trauma
3. used steroids more than 14 days within the last 3 months
4. treated with chemotherapy or radiation therapy
5. pregnant or breast feeding
6. had severe depression or other severe psychological conditions

Target sample size

150

Name of lead principal investigator

1st name
Middle name
Last name	Mariko Shiramizu

Organization

Kanagawa University of Human Services

Division name

School of Nursing, Faculty of Health & Social Services

Zip code

Address

1-10-1, Heisei-cho, Yokosuka, Kanagawa

TEL

046-828-2624

Email

shiramizu-m@kuhs.ac.jp

Name of contact person

1st name
Middle name
Last name	Mariko Shiramizu

Organization

Kanagawa University of Human Services

Division name

School of Nursing, Faculty of Health & Social Services

Zip code

Address

1-10-1, Heisei-cho, Yokosuka, Kanagawa

TEL

046-828-2624

Homepage URL

Email

shiramizu-m@kuhs.ac.jp

Institute

Faculty of Health & Social Services, Kanagawa University of Human Services

Institute

Department

Personal name

Organization

Grants-in-Aid for Scientific Research, Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

済生会横浜市南部病院（神奈川県）、川崎市立川崎病院（神奈川県）、川崎市立井田病院（神奈川県）

Date of disclosure of the study information

2014

Year

12

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

This was a randomized controlled study to assess the effectiveness of structured self-monitoring of blood glucose testing among noninsulin-treated type 2 diabetes patients. Patients were recruited and randomized to a control group (CG) with usual care or a structured testing group (STG) at least every other month use of structured self-monitoring of blood glucose (SMBG). STG patients were trained to use a paper tool to collect 7-point glucose profiles over 3 consecutive days. The primary end point was HbA1c level measured at 6 months. The 6-month median HbA1c (IQR) of STG group was 7.2% and that of CG group was 7.6%; there was no statistically significant deference between them. Only the STG group showed significant reductions of median HbA1c from 7.5% to 7.2%.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

09

Month

24

Day

Date of IRB

Anticipated trial start date

2014

Year

12

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

20

Day

Last modified on

2017

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018618